Prodisc-Oblique. Modular disc prosthesis for anterolateral

Prodisc-Oblique. Modular disc
prosthesis for anterolateral approach.
Technique Guide
Image intensifier control
Warning
This description alone does not provide sufficient background for direct use of
the product. Instruction by a surgeon experienced in handling this product is
highly recommended.
Note
Attending training is mandatory. Please contact your local Synthes representative
for further information.
Reprocessing, Care and Maintenance of
Synthes Instruments
For general guidelines, function control and dismantling of multi-part instruments,
please contact your local sales representative or refer to:
www.synthes.com/reprocessing
Table of Contents
Introduction
Surgical Technique
Product Information
Prodisc-Oblique
2
Indications and Contraindications
4
Kinematics
6
Five Rules for Successful Insertion
8
Preoperative Planning
9
Patient Positioning
11
Approach
12
Endplate Preparation and Segment Mobilization
13
Implant Insertion
16
Implants
32
Instruments
33
Vario Cases and Sets
38
Other Synthes Products for Access, Discectomy and
Endplate Preparation
40
Bibliography
43
Synthes
1
Prodisc-Oblique. Modular disc
prosthesis for anterolateral approach.
Proven design
Modular design for individual implant assembly
Superior plate with obliquely
positioned keel
– Keel specially developed for anterolateral
approach
– Optimum lordosis adjustment of 3° or 6° angle
PE inlay
– Articulates with the superior plate
– Determines the implant height (10, 12 or
14 mm)
Inferior plate with obliquely
positioned keel
– Acts as a foundation for the PE inlay
– Secure locking of the inlay by a snap
mechanism
– Optimum lordosis adjustment of 0° or 3° angle
2
Synthes
Prodisc-Oblique
Technique Guide
Minimally invasive
anterolateral approach
Minimal invasive access
– Less mobilization of major vessels and the hypogastric
plexus
– Reduced risk of interrupting blood circulation in the left leg
– Significantly reduced risk of arterial thromboembolism
– Reduced risk of plaque embolism with arteriosclerosis
Surgical technique
– High precision in positioning prosthesis with specially
developed instruments
– Modular prosthesis structure for an optimum and frictionless positioning
Ball and socket principle
– Preserves mobility of the functional
spinal unit
– Preserves the physiological range of
motion
– Minimizes the segmental shearing forces
– Significantly reduces the compensationrelated loading of adjacent segments
Good primary and secondary stability
– Central keel for implant anchorage in the bone
– Optimum osteointegration and high resistance to friction
with rough titanium surface coating
Reliable, tested materials
– Cobalt–chromium–molybdenum
(CoCrMo) implant plates
– Titanium surface coating supports osteointegration and provides high frictional
resistance
– Insert consists of ultra-high-molecular
weight polyethylene (UHMWPE) and has
a tantalum marker for visualization.
Synthes
3
Indications and Contraindications
Intended use
Prodisc-Oblique implants are used to replace lumbar intervertebral discs and to restore disc height and segmental
motion at vertebral levels L1 to L5. They are inserted by using
the antero-lateral approach.
Indications
Lumbar discopathy for levels L1 to L5, for which patient’s
anatomy allows the antero-lateral approach.1
Contraindications
– Vertebral level L5/S1
– Any circumstances preventing antero-lateral access to the
spinal column (including extensive abdominal and/or
retroperitoneal surgery from the left)
– Compromised vertebral bodies at affected level due to
current or past trauma (fractures)
– Substantial loss of disc height, where applied segmental
distraction may lead to damage of the great vessels
– Isolated radicular compression syndromes, especially due
to disc herniation
– Bony lumbar spinal stenosis
– Spondylolysthesis/Retrolisthesis
– Pars defect
– Complete laminectomy
– Osteoporosis and osteopenia2
– Active systemic infection or infection localized to the site
of implantation
– Allergy or sensitivity to implant materials (foreign body
sensitivity to the implant materials)
– Adipositas
– Pregnancy
– Involved vertebral endplate dimensionally smaller than the
minimum implant footprint size in both the medial-lateral
and the anteriorposterior directions
– Severe abnormality of the endplate (e.g. large Schmorl
nodes)
– Facet joint disease or degeneration
1
The accessibility of the disc segment L1/L2 depends on the patient’s individual
anatomy
2
Bone density T index <-2 SD, according to DXA/DEXA, dual-X-ray apsorptiometry
4
Synthes
Prodisc-Oblique
Technique Guide
–
–
–
–
–
–
–
–
–
Systemic and/or metabolic diseases
Back or leg pain of unknown etiology
Active malignancy (e.g. tumors)
Acute or chronic infections (systemic and/or local)
Dependency on pharmaceutical drugs or drug abuse,
or alcoholism
Predominant psychosocial factors/illnesses
Foraminal or lateral spinal canal stenosis
Lack of patient compliance
Any cases not listed in the indications
Patient exclusion recommendations
In selecting patients for total disc replacement, the following
factors are important for the outcome and success of the
procedure:
– The patient’s occupation or activity level
– A condition of senility or mental illness
– Smoking, alcohol consumption or drug use
Synthes
5
Kinematics
The kinematics of the Prodisc-O prosthesis correspond to the
physiological movement profile within the disc joints:3
The rotational center is only just below the superior endplate of the affected caudal vertebral body. The location of
the center of rotation and the flexion radius correspond to
the natural joint guidance in the vertebral joints. This allows
the physiological range of motion in terms of the flexion/
extension and the lateral inclination to be fully restored. The
axial rotation is limited only by the anatomical structures
and not by the prosthesis. Pure translatory movements in
connection with the implant are not possible due to the ball
and socket principle.
Flexion/extension
15°
10°
3
See White, Panjabi 1990; Pearcy, Portek, Shepherd 1984; Pearcy, Tibrewal 1984;
Dvorak et al 1991
6
Synthes
Prodisc-Oblique
Technique Guide
5°
20°
13°
7°
Lateral bending
10°
5°
20°
5°
10°
10°
Axial rotation
6°
3°
3°
360°
Synthes
7
Five Rules for Successful Insertion
1a. Do not use if the segmental distraction is insufficient or
can damage the anatomical structures due to substantial
loss of disc height.
1b. Careful symmetrical mobilization of the affected segment is essential.
2. Never use Prodisc-O implants where bone density is
T < –2.4
3. The inferior and superior plate of the implant have to be
positioned in parallel and have to line up directly. The
distance of the implant to the posterior edge of the disc
should be 1–1.5 mm.
4. The central positioning of the implant plates from an
anterior to posterior view is crucial to ensure proper
function of the prosthesis.
5. After inserting the PE inlay always ensure that it is locked
in position.
4
Bone density T index <-2 SD, according to DXA/DEXA, dual-X-ray apsorptiometry
8
Synthes
Prodisc-Oblique
Technique Guide
Preoperative Planning
A detailed and correct assessment of the indication is the key
for successful results in arthroplasty.
If conservative treatment methods have failed to yield positive results, a diagnosis can be made on the basis of the indication profile as to whether the use of an artificial disc could
be a promising option for the patient in question.
Basic diagnosis
– X-ray, anterior/posterior (AP) and lateral
– X-ray, flexion/extension and lateral inclination (patient
standing)
– Magnetic resonance imaging (MRI)
Further diagnostics
Non-invasive:
– Computer tomography (CT)
– Three-dimensional CT angiography
– Bone densitometry (T-score not less than -2)
MRI/CT
Preoperative, AP
Preoperative, lateral
Invasive:
– Discography
– Facet blocks (radiologically confirmed, intra-articular facet
joint infiltration)
– Nerve root blocks (radiologically confirmed radicular
infiltration)
– Iliosacral joint block (intra-articular infiltration of the
iliosacral joint)
Synthes
9
Preoperative Planning
X-ray templates
X000053
X-ray Template for Prodisc-O, size M
X000054
X-ray Template for Prodisc-O, size L
The X-ray templates are used to plan the position, footprint,
height and lordosis angle of the prosthesis to be used.
This generally requires X-rays to be taken in two planes,
AP and lateral. The height is assessed on the basis of
the AP image on the healthy lumbar segment. The depth
and the lordosis angle can be determined on the basis of the
lateral images.
To make it easier to select the most suitable implant, all
heights and possible lordosis angles should be separately
listed on the X-ray template.
If CT images are available, the footprint can also be selected
by sagittal images. The axes shown on the template show
the center of the prosthesis where the center of rotation for
the implant is found.
10
Synthes
Prodisc-Oblique
Technique Guide
Patient Positioning
The correct patient positioning is essential for carrying out
surgery.
1
2
The patient should lay on an adjustable and radiolucent operating table that allows the orthograde use of a C-arm in an
anteroposterior and mediolateral plane.
Generally a neutral standard position is recommended in
which the legs are parallel and extended and the arms are
extended at right angles. (1)
For combined surgery in the L4/L5 segment and L5/S1 segment the “Da Vinci position” is recommended. (2)
It is also important to ensure that the patient is positioned
far towards the foot end of the table, to allow an orthograde
projection of each segment with the C-arm. (3)
The pulse oximeter should be fitted to the upper extremity
because of the risk of compromising the vessels on the left
big toe.
3
Synthes
11
Approach
Recommended systems
187.310
SynFrame Basic System in Vario Case
01.609.102
Set SynFrame RL, lumbar
Make an anterolateral incision on the left at the level of the
endplate projection of the disc segment to be treated. Use a
retroperitoneal approach to the disc segment. If necessary,
ligate the V. lumbalis ascendens or the intersegmental vessels.
Mobilize the major vessels to the midline. Secure the site
using the appropriate device.
Site
Notes
– The SynFrame retraction system is recommended to ensure
the secure preparation of the operative field.
– In view of the minimally invasive surgical technique, suitable illumination of the surgical field by a headlamp or operating microscope is recommended.
– The major vessels should be sufficiently mobilized to avoid
the risk of damaging the vessels when the implant is inserted.
12
Synthes
Prodisc-Oblique
Technique Guide
Vessels
Endplate Preparation and Segment
Mobilization
1
Mark the midline
Exact determination of the midline is required to ensure precise positioning of Prodisc-O in the intervertebral disc space.
This must be exactly in the midline between the two pedicle
projections (“face of an owl”). Both pedicles should be
shown equally large and should be the same distance from
the lateral disc outline.
Mark the midline with a permanent marking (e.g. with a
chisel).
Note: Marks made by mono/bipolar coagulation are often
no longer visible after a discectomy. In addition, monopolar
coagulation can lead to permanent damage to the hypogastric plexus.
Synthes
13
Endplate Preparation and Segment Mobilization
2
Discectomy and endplate preparation
1
Recommended instruments
01.600.100
Proprep Set
SFW580R
Prodisc-L Elevator
Complete removal of the intervertebral disc tissue, particularly the posterolateral area of the disc space, so as to expose
the PLL is important for the successful outcome of the operation. (1)
Completely remove the cartilaginous endplates to clearly
expose the bony endplates (2). To minimize the risk of
implant subsidence, ensure that the bony endplates remain
fully intact during this process.
Note: Modification of the bony endplates is rarely needed in
order to ensure correct seating of the implant. Areas that
are not in contact with bone at the time of implantation are
usually no longer detectable after 3 to 6 months thanks to
bone remodeling.
14
Synthes
Prodisc-Oblique
Technique Guide
2
3
Mobilize segment
Instruments
SFW550R
Prodisc-L Spreader (straight)
SFW650R
Prodisc-L Spreader Forceps, curved
Sufficient mobilization that is equal on all sides is the key to
successful implant seating and its later functionality.
Note: Unlike the fusion procedure the process to achieve full
segment mobility is considerably more complex.
To check for adequate mobility, completely insert the
spreader forceps/spreader down to the posterior part of the
disc space (1) under lateral image intensifier control and perform parallel distraction of the segment (2).
1
Note: A substantial loss in disc height can result in over
stretching or injuring adjacent anatomic structures.
2
Synthes
15
Implant Insertion
1
Select and assemble trial implant
Instruments
03.821.101
Handle for Trial Implants
03.821.021–029 Trial Implants, size M
03.821.041–049 Trial Implants, size L
03.821.139
Centering Device
314.270
Hex Screwdriver, large, ⭋ 3.5 mm,
with groove, length 240 mm
Optional
03.821.011–019 Trial Implants, size M, narrow
03.821.021–039 Trial Implants, size L, narrow
The following are determined with the trial implant:
– Lordosis angle
– Height
– Footprint size
– Keel chisels
– Implant position
The correct choice and positioning is essential for the success
of the procedure.
Rules for selecting the appropriate trial implant:
– Largest possible endplate cover
– Smallest possible height
– Restoration of the natural lordosis angle
The x-ray images and the x-ray templates can give a guide as
to the correct trial implant. 18 trial implants are available.
The trial implants are color-coded and list the height
(see item list on page 33):
height 10 mm: green
height 12 mm: blue
height 14 mm: bronze (optional)
16
Synthes
Prodisc-Oblique
Technique Guide
Screw the handle � and the centering device � to the
appropriate trial implant �.
Note: If using the optional narrow trial implants, ensure that
despite the smaller dimensions (compared to the final
implant) there is sufficient space to use the later implant.
�
�
�
Synthes
17
Implant Insertion
2
1
Position trial implant
Instruments
03.821.133/134 Fixation Post, length 200 mm / 250 mm
03.821.138
Socket Wrench ⭋ 6 mm with Cardan Joint
Optional
03.821.132
Tappet
Align the trial implant in the anteroposterior x-ray plane at
the midline. (1)
Align the trial implant in an orthograde medial position with
the aid of the radiolucent, rectangular cut-outs. The cut-outs
must be clearly visible in full size in an x-ray image set in an
orthograde position. (2)
Set the trial implant under lateral x-ray control so that the
posterior edge of the trial implant is approximately
1–1.5 mm from the posterior edge of the disc space. The
lateral, radiolucent, rectangular cut-outs must be clearly
visible in full size in an x-ray image set in a lateral position. (3)
Check the final position in both planes. Both radiolucent,
rectangular cut-outs in the orthograde AP image and in the
lateral x-ray must be clearly visible. If one or more attempts
are required to reposition the trial implant until the optimum
position is found, an x-ray should be taken in both planes
after each correction.
18
Synthes
Prodisc-Oblique
Technique Guide
2
3
Secure the handle and the centering device to the retraction
system with the fixation posts and then tighten (4). When
tightening ensure that the position of the trial implant is not
in any way changed and that the chisel can later by inserted
into the trial implant.
4
Notes
– Do not use the trial implant to mobilize the segment.
– Prepare the keel slots only after the trial implant has been
correctly seated in an orthograde position. Positioning in
the correct axial alignment and secure fixation of the trial
implant to the SynFrame are key factors for the subsequent implant positioning.
Correct positioning
Possible errors and effects
Synthes
19
Implant Insertion
3
1
Prepare keel slots
Instruments
03.821.135
Chisel
03.821.105
Slide Hammer, with Connector, long
SFW691R
Combined Hammer
Insert the first chisel caudally over the trial implant handle.
Push the chisel blade forwards on the shaft of the trial implant handle, thread into the trial implant guide and use the
hammer to tap it in about one third of the way.
Cranially insert the second chisel in the same way as the first
and also hammer in one third of the way (1). Then hammer
in each chisel alternately to the stop position under x-ray
control (2).
Finally hammer out both chisels with the slap hammer. (3)
Notes
– The chisel may only be used with the inserted trial implant.
– The required keel slots may only be made with the appropriate chisel.
– Always insert the chisel under x-ray control.
– Do not use damaged and/or blunt chisels.
20
Synthes
Prodisc-Oblique
Technique Guide
3
2
4
1
Insert strut
Instruments
03.821.121–129 Struts, angled
03.821.138
Socket Wrench ⭋ 6 mm with Cardan Joint
SFW520
Prodisc-L Handle for Strut
Optional
03.821.111–119 Struts, straight
Struts are used in order to prevent the segment from collapsing when the trial implant is removed.
2
Unscrew the centering device and fit an angled strut to the
medial side of the trial implant. (1)
A straight strut can be placed laterally as a further optional
aid. Adjust the straight strut according to the height of the
disc and the depth of the surgical field. (2)
Secure the strut to the SynFrame using the handle for strut
and remove the trial implant. (3)
Caution: Always position the strut first and then remove the
trial implant.
3
Synthes
21
Implant Insertion
5
1
Assemble the inserter
Instruments
03.821.143
Inserter, size M
03.821.145
Inserter, size L
314.270
Hex screwdriver, large, ⭋ 3.5 mm,
with groove, length 240 mm
2
3
The inserters are available for implant sizes M and L.
The arms can be removed.
Screw on the superior plate holders
Screw the holder mechanisms of the superior plate to the
superior arm of the inserter with the appropriate screw and
the hex screwdriver. (1)
Assemble the inferior arms to the holder block
Secure the arm labelled “LEFT” to the left part of the holder
block by pressing the locking mechanism on the holder block
(2), inserting the arm in the position “LOOSE” and then turning inwards by 90° to the “LOAD” position (3).
Proceed in the same way with the arm labelled “RIGHT” to
fit it to the right half of the holder block. (4)
22
Synthes
Prodisc-Oblique
Technique Guide
4
Right
Left
6
Select implant size
Selecting the implant combinations
– Take the size of the footprint from the trial implant.
– Check the height on the trial implant and use a PE-inlay
that is the same height and size.
– Check the lordosis angle on the trial implant. The angle
can be divided between the superior and inferior plates.
– Where there is an inclination of over 3°, use an inferior
plate with 3° angle and fill the necessary lordosis angle
with the superior plate.
– Where there is an inclination of less than 3°, use an
inferior plate with 0° angle and represent the necessary
lordosis angle with the superior plate.
Lordosis
angle
Horizontal line
Inclination
Result: 3° 6° 9°
Lordosis curve
Caution: Size M and L for the implant components may
never be combined.
Lordosis angle: Angle between caudal endplate of superior segment and cranial
endplate of inferior segment
Inclination: Angle between horizontal line and cranial endplate of inferior segment
Synthes
23
Implant Insertion
7
Fit the implant plates
1
2
3
4
Caution: Always check all components to ensure they are
not damaged before assembling the implant components.
Fit the inferior implant plate to the inserter (1) and turn both
arms inwards by 90°. This secures the plate in the “LOCK”
position (2).
Place the superior plate sideways on the cylinder shaped end
of the superior arm (3). The keel must always be in the axis
of the upper arm, i.e. should form a line. This makes it easier
to fit the implant.
Caution: After fitting the implant components to the
inserter always hold the inserter so that the inferior and
superior plate firmly interlock (4).
24
Synthes
Prodisc-Oblique
Technique Guide
8
Secure and insert implant
1
Instruments
03.821.142
Guiding Device for Inserter, size M
03.821.144
Guiding Device for Inserter, size L
03.821.143
Inserter, size M
03.821.145
Inserter, size L
Before inserting the implant secure the superior plate with
the guiding device. This prevents the superior arm from loosening as a result of tissue pressure on the upper implant
plate.
Position the guide between the arms of the inserter and
push towards the implant. Secure the handle of the guiding
device in the hole at the back part of the inserter. (1)
2
Insert the inferior and superior plate in the bone keel slots (2).
Use a hammer to insert the implant plates under image intensifier control into their final position within the disc space.
Remove the guiding device from the inserter. Remove the
struts.
Synthes
25
Implant Insertion
9
1
Insert PE inlay into instrument
Lay the PE inlay as shown on the instrument (“dome up”) in
the slot of the inserter. (1)
Insert the PE inlay to the first stop. (2)
Note: Insert the PE-inlay with the fingers only up to the first
stop. Always use the distractor to insert the inlay, otherwise
it may become damaged.
2
26
Synthes
Prodisc-Oblique
Technique Guide
10
1
Distract for inlay insertion
Instruments
03.821.151
Distractor, size M, height 10 mm
03.821.154
Distractor, size L, height 10 mm
03.821.152
Distractor, size M, height 12 mm
03.821.155
Distractor, size L, height 12 mm
Optional
03.821.153
Distractor, size M, height 14 mm
03.821.156
Distractor, size L, height 14 mm
SFW582R
Lever for Insertion Instruments
2
Select the appropriate distractor for the implant height and
insert into the appropriate holder block with the hex screw
for the wing nut. (1, 2)
Push the distractor over the guide tracks up to the PE inlay.
Turn the wing nut on the distractor all the way down to
achieve full distraction. The inlay is automatically advanced
by the distractor during this operation. (3)
3
If the forces exerted on the wing nut make it difficult to
screw it in, the lever for insertion instruments can be used as
an extended lever arm. Place the lever in the appropriate
hole in the wing nut.
Note: If there is great resistance, the implant has to be
removed again and the release, the mobilization and
the height gain have to be improved. If the necessary height
is not achieved, the resection of the anterior longitudinal
ligament should be considered. The PE inlay used must be
replaced by a new inlay.
Synthes
27
Implant Insertion
11
1
Lock PE inlay in position
Instruments
03.821.157
Inserter for PE Inlay, size M
03.821.158
Inserter for PE Inlay, size L
Advance the PE inlay between both implant plates with the
inserter (1) until they snap into the inferior plate of the
implant. This can be checked by means of a mark on the
inserter (2).
Finally remove the inserter for PE inlay.
Caution: The inserter for PE inlay must never be advanced
with the hammer, but must be slowly and carefully pushed in
by hand.
After removing the inserter for PE inlay check that the PE
inlay is securely locked. Then discontinue distraction and remove the distractor.
28
Synthes
Prodisc-Oblique
Technique Guide
2
12
Inspection for correct implant positioning
Correct
– PE inlay completely locked in position
– Prosthesis in neutral position
Possible errors in implant positioning
It is crucial to check visually and manually if the PE insert is
securely locked into the inferior implant plate (“NO STEP,
NO GAP”).
Caution: The actual position of the prosthesis can only be
seen once the PE inlay is pushed in. The prosthesis should be
in a neutral position after completing this step.
Flexion
Extension
Lateral bending
Synthes
29
Implant Insertion
13
1
Remove inserter
Instruments
SFW582R
Lever for Insertion Instruments
SFW550R
Prodisc-L Spreader (straight)
03.821.105
Slide Hammer with Connector, long
03.821.136
Extraction Tool for Inserter
Before the inserter can be removed from the implant plates,
check and record the final position of the implant in a lateral
and AP plane using the image intensifier.
Unlock the inferior plate by rotating the lower arms outwards (“LOAD” position) (1). The use of a lever for insertion
instruments can facilitate the rotation of the inserter arms,
if necessary.
Press the upper arm medially and pull the inserter straight
back.
The use of the spreader can facilitate loosening of the superior plate from the inserter. To do this, place the spreader
between the superior arm and the inferior arms and then
distract slightly. The counter-pressure releases the superior
plate from the holder mechanism. (2)
30
Synthes
Prodisc-Oblique
Technique Guide
2
Synthes
31
Implants
Plates, sterile
09.821.023S
Prodisc-O Superior Plate, size M, 3°
09.821.043S
Prodisc-O Superior Plate, size L, 3°
09.821.026S
Prodisc-O Superior Plate, size M, 6°
09.821.046S
Prodisc-O Superior Plate, size L, 6°
09.821.120S
Prodisc-O Inferior Plate, size M, 0°
09.821.140S
Prodisc-O Inferior Plate, size L, 0°
09.821.123S
Prodisc-O Inferior Plate, size M, 3°
09.821.143S
Prodisc-O Inferior Plate, size L, 3°
Polyethylene inlays, sterile
08.821.020S
Prodisc-O PE-Inlay with X-ray Marker,
size M, 10 mm
08.821.040S
Prodisc-O PE-Inlay with X-ray Marker,
size L, 10 mm
08.821.022S
Prodisc-O PE-Inlay with X-ray Marker,
size M, 12 mm
08.821.042S
Prodisc-O PE-Inlay with X-ray Marker,
size L, 12 mm
08.821.024S
Prodisc-O PE-Inlay with X-ray Marker,
size M, 14 mm
08.821.044S
Prodisc-O PE-Inlay with X-ray Marker,
size L, 14 mm
32
Prodisc-Oblique
Synthes
Technique Guide
Instruments
The trial implants and struts are color-coded:
For insertion of 10 mm implants: green
For insertion of 12 mm implants: blue
For insertion of 14 mm implants: bronze (optional)
Optional
Trial Implants
03.821.011
Trial Implant, size M, 3°, 10 mm, narrow
03.821.014
Trial Implant, size M, 6°, 10 mm, narrow
03.821.017
Trial Implant, size M, 9°, 10 mm, narrow
03.821.012
Trial Implant, size M, 3°, 12 mm, narrow
03.821.015
Trial Implant, size M, 6°, 12 mm, narrow
03.821.018
Trial Implant, size M, 9°, 12 mm, narrow
03.821.021
Trial Implant, size M, 3°, 10 mm
03.821.013
Trial Implant, size M, 3°, 14 mm, narrow
03.821.024
Trial Implant, size M, 6°, 10 mm
03.821.016
Trial Implant, size M, 6°, 14 mm, narrow
03.821.027
Trial Implant, size M, 9°, 10 mm
03.821.019
Trial Implant, size M, 9°, 14 mm, narrow
03.821.022
Trial Implant, size M, 3°, 12 mm
03.821.031
Trial Implant, size L, 3°, 10 mm, narrow
03.821.025
Trial Implant, size M, 6°, 12 mm
03.821.034
Trial Implant, size L, 6°, 10 mm, narrow
03.821.028
Trial Implant, size M, 9°, 12 mm
03.821.037
Trial Implant, size L, 9°, 10 mm, narrow
03.821.023
Trial Implant, size M, 3°, 14 mm
03.821.032
Trial Implant, size L, 3°, 12 mm, narrow
03.821.026
Trial Implant, size M, 6°, 14 mm
03.821.035
Trial Implant, size L, 6°, 12 mm, narrow
03.821.029
Trial Implant, size M, 9°, 14 mm
03.821.038
Trial Implant, size L, 9°, 12 mm, narrow
03.821.041
Trial Implant, size L, 3°, 10 mm
03.821.033
Trial Implant, size L, 3°, 14 mm, narrow
03.821.044
Trial Implant, size L, 6°, 10 mm
03.821.036
Trial Implant, size L, 6°, 14 mm, narrow
03.821.047
Trial Implant, size L, 9°, 10 mm
03.821.039
Trial Implant, size L, 9°, 14 mm, narrow
03.821.042
Trial Implant, size L, 3°, 12 mm
03.821.045
Trial Implant, size L, 6°, 12 mm
03.821.048
Trial Implant, size L, 9°, 12 mm
03.821.043
Trial Implant, size L, 3°, 14 mm
03.821.046
Trial Implant, size L, 6°, 14 mm
03.821.049
Trial Implant, size L, 9°, 14 mm
Synthes
33
Instruments
Struts
03.821.111
Strut, straight, height 10 mm, L1
03.821.114
Strut, straight, height 10 mm, L2
03.821.117
Strut, straight, height 10 mm, L3
03.821.112
Strut, straight, height 12 mm, L1
03.821.115
Strut, straight, height 12 mm, L2
03.821.118
Strut, straight, height 12 mm, L3
03.821.113
Strut, straight, height 14 mm, L1
03.821.116
Strut, straight, height 14 mm, L2
03.821.119
Strut, straight, height 14 mm, L3
03.821.121
Strut, angled, height 10 mm, L1
03.821.124
Strut, angled, height 10 mm, L2
03.821.127
Strut, angled, height 10 mm, L3
03.821.122
Strut, angled, height 12 mm, L1
03.821.125
Strut, angled, height 12 mm, L2
03.821.128
Strut, angled, height 12 mm, L3
03.821.123
Strut, angled, height 14 mm, L1
03.821.126
Strut, angled, height 14 mm, L2
03.821.129
Strut, angled, height 14 mm, L3
34
Prodisc-Oblique
Synthes
Technique Guide
03.821.101
Handle for Trial Implants
03.821.105
Slide Hammer with Connector, long
03.821.132
Tappet
03.821.133
Fixation Post, 200 mm
03.821.134
Fixation Post, 250 mm
03.821.135
Chisel
03.821.138
Socket Wrench ⭋ 6.0 mm
with Cardan Joint
03.821.139
Centering Device
SFW520
Handle for Strut
SFW550R
Prodisc-L Spreader
SFW580R
Prodisc-L Elevator
SFW582R
Prodisc-L Lever, for Insertion Instruments
SFW650R
Prodisc-L Spreader Forceps, curved
Synthes
35
Instruments
Insertion instruments and distractors are color-coded. Color
coding in the Vario Case indicates the instrument size:
Size M: Violet ring
Size L: Yellow ring
03.821.143
Inserter, size M
03.821.145
Inserter, size L
03.821.151
Distractor, size M, height 10 mm
03.821.152
Distractor, size M, height 12 mm
03.821.153
Distractor, size M, height 14 mm
03.821.154
Distractor, size L, height 10 mm
03.821.155
Distractor, size L, height 12 mm
03.821.156
Distractor, size L, height 14 mm
03.821.157
Inserter for PE Inlay, size M
03.821.158
Inserter for PE Inlay, size L
03.821.136
Extraction Tool for Inserter
03.821.142
Guiding Device for Inserter, size M
03.821.144
Guiding Device for Inserter, size L
36
Prodisc-Oblique
Synthes
Technique Guide
387.347
SynFrame Clamp for Holding Ring
No. 387.336
314.270
Screwdriver, hexagonal, large, ⭋ 3.5 mm,
with Groove, length 240 mm
387.333
SynFrame Extension, with Joint
387.334
SynFrame Extension, with Joint, with Snapin Locking
X-ray templates
X000053
X-ray Template for Prodisc-O, size M
X000054
X-ray Template for Prodisc-O, size L
Spare parts
60064875
Superior Arm Tip, complete
60007955
Screw for Superior Arm
60008845
Inferior Arm, right, complete
60008843
Inferior Arm, left, complete
SFW692
Prodisc-L Mallet Impact Surface
Synthes
37
Vario Cases and Sets
Vario Cases
68.821.001
Vario Case for Prodisc-O Insertion
Instruments
68.821.002
Vario Case for Prodisc-O Preparation
Instruments
38
Prodisc-Oblique
Synthes
Technique Guide
68.821.003
Vario Case for Prodisc-O Additional
Instruments
Sets
01.821.001
Prodisc-O Set Insertion and Preparation
Instruments
01.821.002
Prodisc-O 14 mm Set
The sets contain the Vario Cases and required instruments,
along with a full set of implants.
Synthes
39
Other Synthes Products for Access,
Discectomy and Endplate Preparation
SynFrame
Set
01.609.102
Set SynFrame RL, lumbar
187.310
SynFrame Basic System in Vario Case
Information material
036.000.066
SynFrame, Flyer
036.000.695
SynFrame RL, Flyer
The SynFrame System is a modular approach and retraction
system consisting of a basic system (basic construction)
and modules specially designed for specific requirements and
applications of various indications and/or approach techniques. The structure of the SynFrame basic system is always
in the same sequence and according to the same principles.
SynFrame RL lumbar is an additional module for the approach and retraction system SynFrame. It includes radiolucent soft tissue and muscle retractors and semi-transparent
bone levers for minimally invasive procedures.
40
Synthes
Prodisc-Oblique
Technique Guide
Proprep
Set
01.600.100
Set Proprep
Information material
036.000.760
Proprep, Flyer
A practically arranged set for disc preparation and vertebral
compression for surgery on the lumbar spine with anterior
access.
– Compact yet comprehensive: contains all instruments
necessary for disc preparation and vertebral compression.
– Simplified thanks to the angled instruments that allow
access even to the posterolateral disc regions, the entire
anterior discectomy and corpectomy.
– Thanks to the low-profile instrument it is ideal for use in
severely collapsed segments.
– The instrument length has been specifically designed for
anterior approaches and patients with a high BMI.
– Maximum instrument control thanks to the silicone
handles that can be grasped with both hands.
Synthes
41
Other Synthes Products for Access, Discectomy and Endplate
Preparation
Electric Pen Drive and Air Pen Drive
Instruments
05.001.055
Burr Attachment XXL, 20°,
for EPD and APD
Information material
036.000.097
E-Pen Drive, Flyer
036.000.502
Air Pen Drive, Flyer
Compact drive units with specific attachments for a wide
range of applications. An optimised attachment to prepare
the endplate for Prodisc insertion is available.
42
Synthes
Prodisc-Oblique
Technique Guide
Bibliography
Studies on Prodisc, the artificial intervertebral disc
Bae H, Kanim LEA, Sra P, Delamarter R, Kropf M (2004)
Prodisc lumbar disc replacement vs fusion: preservation of
motion and patient self assessment at 1- to-2–year follow
up. Spine J 4 (5): 12
Berry JL, Moran JM, Berg WS, Steffee AD (1987) A morphometric study of human lumbar and selected thoracic
vertebrae. Spine 12 (4): 362–367
Bertagnoli R, Marnay T, Mayer HM (2005) Total disc replacement for degenerative disc disease in the lumbar spine.
2nd ed. Oberdorf, Synthes
Bertagnoli R, Yue JJ, Fenk-Mayer A, Eerulkar J, Emerson JW
(2006) Treatment of symptomatic adjacent-segment degeneration after lumbar fusion with total disc arthroplasty by
using the Prodisc prosthesis: a prospective study with 2-year
minimum follow up. J Neurosurg Spine 4(2): 91–97
Bertagnoli R, Yue JJ, Kershaw T, Shah RV, Pfeiffer F, FenkMayer A, Nanieva R, Karg A, Husted DS, Emerson JW (2006)
Lumbar total disc arthroplasty utilizing the ProDisc prosthesis
in smokers versus nonsmokers: a prospective study with
2-year minimum follow-up. Spine 31(9): 992-97
Chung SS, Lee CS, Kang CS (2006) Lumbar total disc replacement using Prodisc II: a prospective study with a 2-year
minimum follow-up. J Spinal Disord Tech (6): 411-415
Delamarter RB, Fribourg DM, Kanim LE, Bae H (2003) ProDisc
artificial total lumbar disc replacement: introduction and
early results from the United States clinical trial. Spine 28(20):
167–175
Dvorak J, Panjabi MM, Chang DG, Theiler R, Grob D (1991)
Functional radiographic diagnosis of the lumbar spine –
flexion-extension and lateral bending. Spine 16 (5): 562–
Hannibal M, Thomas DJ, Low J, Hsu KY, Zucherman J. (2007)
Prodisc-L total disc replacement: a comparison of
1-level versus 2-level arthroplasty patients with a minimum
2-year follow-up. Spine 32(21): 2322-2326
Huang RC, Girardi FP, Cammisa Jr FP, Tropiano P, Marnay T
(2003) Long-term flexion-extension range of motion of the
Prodisc total disc replacement. J Spinal Disord Tech 16(5):
435–440
Leivseth G, Braaten S, Frobin W, Brinckmann P (2006)
Mobility of lumbar segments instrumented with a ProDisc II
prosthesis: a two-year follow-up study. Spine 31(15):
1726–1733
Pearcy M, Portek I, Shepherd J (1984) Three-dimensional
X-ray analysis of normal movement in the lumbar spine.
Spine 9 (3): 294–297
Pearcy MJ, Tibrewal SB (1984) Axial rotation and lateral
bending in the normal lumbar spine measured by threedimensional radiography. Spine 9 (6): 582–591
Siepe CJ, Mayer HM, Wiechert K, Korge A (2006) Clinical
results of total lumbar disc replacement with ProDisc II:
three-year results for different indications. Spine 31(17):
1923–1932
Tropiano P, Huang RC, Girardi FP, Marnay T (2003) Lumbar
disc replacement: preliminary results with Prodisc® II after a
minimum follow-up period of 1 year. J Spinal Disord Tech 16
(4): 362–368
Tropiano P, Huang RC, Girardi FP, Cammisa FP, Marnay T
(2005) Lumbar total disc replacement. Seven to Eleven-Year
Follow-Up. J Bone Joint Surg Am 87 (3): 490–496
White AA, Panjabi MM (1990): Clinical biomechanics of the
spine. 2nd. ed. Philadelphia, Lippincott.
Gilad I, Nissan M (1986) A study of Vertebra and Disc Geometric Relations of the Human Cervical and Lumbar Spine.
Spine 11 (2): 154–157.
Synthes
43
Bibliography
Yue JJ, Bertagnoli R, Husted DS, Shah R, Kershaw T (2004)
The treatment of disabling multilevel lumbar discogenic low
back pain with total disc arthroplasty utilizing the Prodisc
prosthesis: a prospective study with 2-year minimum follow
up. Spine J 4 (5): 49–50
Zigler JE (2003) Clinical results with ProDisc: European experience and U.S. investigation device exemption study. Spine 28
(20): 163–166
Zigler JE, Burd TA, Vialle EN, Sachs BL, Rashbaum RF,
Ohnmeiss DD (2003) Lumbar spine arthroplasty: early results
using the ProDisc II: a prospective randomized trial of arthroplasty versus fusion. J Spinal Disord Tech 16(4): 352–361
Zigler J, Sachs B, Rashbaum R, Ohnmeiss D (2004) Total disc
replacement using ProDisc 12-to-24–month follow up results
of a prospective randomized comparison to fusion. Spine J 4
(5): 25–26
Zigler J, Delamarter R, Spivak JM, Linovitz RJ, Danielson GO
3rd, Haider TT, Cammisa F, Zucherman J, Balderston R,
Kitchel S, Foley K, Watkins R, Bradford D, Yue J, Yuan H,
Herkowitz H, Geiger D, Bendo J, Peppers T, Sachs B, Girardi F,
Kropf M, Goldstein J (2007) Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the Prodisc-L total disc
replacement versus circumferential fusion for the treatment
of 1-level degenerative disc disease. Spine 32(11):
1155–1162
44
Synthes
Prodisc-Oblique
Technique Guide
Synthes GmbH
Eimattstrasse 3
CH-4436 Oberdorf
www.synthes.com
All technique guides are available as PDF files at
www.synthes.com/lit
0123
036.000.698
Version AC
Ö036.000.698öACMä
03/2012
50147328
© Synthes, Inc. or its affiliates
Subject to modifications
Synthes, Prodisc and Vario Case are a trademarks of Synthes, Inc. or its affiliates